The start of a potentially big biomedical breakthrough is blooming within all of us. Drug research aiming to turn bacteria into microbiome therapies now spans programs aiming to address gut disorders, autism, cancer, and more. Given the number of late-stage and mid-stage studies expected to report data in 2020—assuming they stay on track amid the … Continue reading “Why 2020 Is Pivotal for Microbiome Drug R&D (Or Maybe 2021, Given COVID-19)”
BARDA Director Rick Bright Moves to NIH to Head COVID-19 Testing R&D
Rick Bright, who joined the Biomedical Advanced Research and Development Authority (BARDA) in 2010, has suddenly left his role as director of the federal agency, which is playing a key role in advancing medical countermeasures against COVID-19. BARDA formed in 2006; Bright (pictured) succeeded founding director Robin Robinson to the position in late 2016. The … Continue reading “BARDA Director Rick Bright Moves to NIH to Head COVID-19 Testing R&D”
Cara Therapeutics Itching Drug Scratches Off Goals of Phase 3 Test
A Cara Therapeutics drug developed to treat the severe itching experienced by patients receiving hemodialysis has met the main goal of a second late-stage study, setting up the experimental medicine for regulatory filings in the US and Europe. Cara (NASDAQ: [[ticker:CARA]]) is testing its injectable drug, difelikefalin (Korsuva), in patients who have moderate-to-severe chronic kidney … Continue reading “Cara Therapeutics Itching Drug Scratches Off Goals of Phase 3 Test”
New COVID-19 Special Reports Explore Clinical Research During the Pandemic
Two new special reports on Xconomy Insight provide an expert view on how companies can sustain clinical trials during the COVID-19 crisis. “Decentralized Clinical Trials: The Call for a New Paradigm” and “Sustaining Clinical Research During the Crisis” offer the latest trends and technologies companies can use to keep business running as smooth as possible. … Continue reading “New COVID-19 Special Reports Explore Clinical Research During the Pandemic”
War Paint to Bone Paint: MIT Spinout Aims to Transform Regenerative Meds
Driven by 20 years in the military, the founder of Theradaptive hopes his firm’s regenerative “paint” technology platform can transform bone repair, spinal fusion, and sports medicine. The firm, spun out of MIT, has a computational platform it says turns recombinant proteins into material-binding variants that behave like a paint. This can then be used … Continue reading “War Paint to Bone Paint: MIT Spinout Aims to Transform Regenerative Meds”
Ohana Bio Adds Ramiro Castro-Santamaria as Chief Medical Officer
Ohana Biosciences announced it appointed Ramiro Castro-Santamaria, a urologist and family medicine physician, as its chief medical officer. Castro-Santamaria was most recently vice president of clinical sciences and head of rheumatology at GlaxoSmithKline (NYSE: [[ticker:GSK]]), where he spent 14 years serving in various clinical development and R&D roles. His prior experience includes roles at Boehringer … Continue reading “Ohana Bio Adds Ramiro Castro-Santamaria as Chief Medical Officer”
Sangamo Names Amgen’s D. Mark McClung as Chief Business Officer
Sangamo Therapeutics (NASDAQ: [[ticker:SGMO]]) has appointed D. Mark McClung as executive vice president and chief business officer. Previously McClung was general manager of global oncology commercial at Amgen (NASDAQ: [[ticker:AMGN]]), which he joined from Onyx Pharmaceuticals (acquired by Amgen for about $10 billion in 2013). For two decades prior, he held roles at GlaxoSmithKline (NYSE: … Continue reading “Sangamo Names Amgen’s D. Mark McClung as Chief Business Officer”
Unlearn Adds $12M for “Digital Twins” That Accelerate Clinical Trials
Speeding up and bringing down the cost of clinical trials would be a huge boon to pharma companies and patients alike. San Francisco-based startup Unlearn.AI says it has developed proprietary technology that may help accomplish just that. On Monday the company announced it raised $12 million from investors who believe it stands out among the … Continue reading “Unlearn Adds $12M for “Digital Twins” That Accelerate Clinical Trials”
Rockwell Medical President & CEO Paul Resigns, Ellison Named Successor
Rockwell Medical (NASDAQ: [[ticker:RMTI]]) announced Monday that Stuart Paul has resigned as president and CEO. Paul, who has held the company’s top executive post since 2018, has also stepped down from the Wixom, MI-based company’s board of directors. No reason was given for the resignation. Russell Ellison, who joined Rockwell Medical’s board in January, was named … Continue reading “Rockwell Medical President & CEO Paul Resigns, Ellison Named Successor”
PTC Therapeutics Promotes Matthew Klein, Eric Pauwels to C-Suite
Rare disease drug developer PTC Therapeutics (NASDAQ: [[ticker:PTCT]]) has promoted Matthew Klein to chief development officer. Klein joined the South Plainfield, NJ, biotech last year as global head of gene and mitochondrial therapies. He was previously CEO and chief medical officer of BioElectron Technology. PTC acquired some of BioElectron’s assets in 2019. In other moves, … Continue reading “PTC Therapeutics Promotes Matthew Klein, Eric Pauwels to C-Suite”
FDA Approves Incyte Drug, First Ever for Rare Bile Duct Cancer
The FDA has granted speedy approval for an Incyte drug developed to treat cholangiocarcinoma, a rare cancer affecting the bile ducts. The regulatory nod for the drug, pemigatinib (Pemazyre), comes more than a month earlier than the anticipated May 30 decision date and it makes the pill the first FDA-approved treatment for cholangiocarcinoma. The decision … Continue reading “FDA Approves Incyte Drug, First Ever for Rare Bile Duct Cancer”
Seattle Genetics Gets Early FDA Nod for Breast Cancer Combo Drug
Seattle Genetics on Friday received its third FDA approval, a regulatory nod for a breast cancer drug for patients with an especially aggressive form of the disease, four months ahead of schedule. The Bothell, WA-based biotech earned the earlier-than-expected decision for its oral drug tucatinib (Tukysa), when taken in combination with the chemotherapies trastuzumab and … Continue reading “Seattle Genetics Gets Early FDA Nod for Breast Cancer Combo Drug”
COVID-19 Vax Efforts Aim to Balance Speed, Efficacy in Race to Market
If Peter Marks had a magic wand to perfect the sophisticated process that takes a new vaccine from idea to reality, the US could have a way to prevent some people from COVID-19 infection in nine months to one year. In the real world, the journey to a vaccine OK’d under emergency guidelines is more … Continue reading “COVID-19 Vax Efforts Aim to Balance Speed, Efficacy in Race to Market”
Lantern Pharma IPO File Illuminates Plan to “Rescue” Failed Cancer Drugs
A growing number of drug developers are embracing artificial intelligence as a tool for finding new medicines. Lantern Pharma is betting the technology can also resurrect failed cancer drugs and it is now preparing an initial public stock offering to support their development. Lantern filed its IPO paperwork late Thursday. The Dallas-based company set a … Continue reading “Lantern Pharma IPO File Illuminates Plan to “Rescue” Failed Cancer Drugs”
Bio Roundup: Alnylam’s Billions, COVID-19 Vaccines, Moma Debuts & More
The public markets are moving erratically, but Alnylam Pharmaceuticals showed this week that selling equity isn’t the only way for biotech companies to raise cash. Late last year Alnylam (NASDAQ: [[ticker:ALNY]]) began exploring potential royalty deals for inclisiran, a drug that uses RNA interference to lower cholesterol. Alnylam had sold the drug’s development and commercialization … Continue reading “Bio Roundup: Alnylam’s Billions, COVID-19 Vaccines, Moma Debuts & More”
TearClear Taps Former Shire Executive Robert Dempsey as CEO
Eye drug developer TearClear has appointed Robert Dempsey to serve as its CEO. Demsey was most recently global head of ophthalmology at Shire, which was acquired by Takeda Pharmaceutical (NYSE: [[ticker:TAK]]). TearClear says Dempsey’s hire comes as the company approaches the initial close of a Series B round of funding that could reach up to … Continue reading “TearClear Taps Former Shire Executive Robert Dempsey as CEO”
Imago BioSciences Adds Edgardo Baracchini as Chief Business Officer
Edgardo Baracchini has been appointed chief business officer of Imago Biosciences. His business development experience includes positions at Xencor (NASDAQ: [[ticker:XNCR]]), Metabasis Therapeutics, Elitra Pharmaceuticals, and Agouron Pharmaceuticals. San Francisco-based Imago develops treatments for bone marrow diseases. The company’s lead program, bomedemstat, is in mid-stage testing in myelofibrosis.
Neurology at Forefront of FDA’s Complex Innovative Trial Design Pilot
The coronavirus pandemic has frozen many clinical trials and forced others to adapt in the face of overwhelmed healthcare systems around the world. When activity resumes, trials could look different, with more remote monitoring and decentralized enrollment. They could reflect some of the design evolutions that the US Food and Drug Administration and sponsors have … Continue reading “Neurology at Forefront of FDA’s Complex Innovative Trial Design Pilot”
RDMD Lands $14M to Expand Reach of Rare Disease Research Platform
Thousands of diseases occur so infrequently that few data are readily available about the patients who have them. RDMD, which launched in 2018 to gather such data to spur more drug research for those patients, has raised $14 million to add 20 more diseases to its platform. The San Francisco-based startup operates a two-sided network. … Continue reading “RDMD Lands $14M to Expand Reach of Rare Disease Research Platform”
UroGen Makes Chief Commercial & Chief Development Officer Promotions
UroGen Pharma (NASDAQ:[[ticker:URGN]]) has added two of its senior employees to the C-suite. The Princeton, NJ-based company, which Wednesday received FDA approval of its lead drug, promoted its senior vice president of commercial, Jeff Bova, to chief commercial officer, and its senior vice president of clinical development, Elyse Seltzer, to chief development officer. Bova and … Continue reading “UroGen Makes Chief Commercial & Chief Development Officer Promotions”
UroGen Gets FDA Nod for Low-Grade Upper Tract Urothelial Cancer Drug
The FDA on Wednesday approved a drug developed by UroGen Pharma to treat low-grade upper tract urothelial cancer, which rarely spreads but often recurs and can cause kidney damage in some patients. Urothelial cancer is the most common type of bladder cancer. Upper tract urothelial cancer (UCTC), however, affects the lining of the urinary system, … Continue reading “UroGen Gets FDA Nod for Low-Grade Upper Tract Urothelial Cancer Drug”
Ex-Regeneron Exec Graham Named Evelo Bio Chief Development Officer
Neil Graham has joined Evelo Biosciences (NASDAQ: [[ticker:EVLO]]) as its chief development officer. He was most recently vice president of immunology and inflammation at Regeneron Pharmaceuticals (NASDAQ: [[ticker:REGN]]). Graham’s experience also includes positions at Vertex Pharmaceuticals (NASDAQ: [[ticker:VRTX]]) and Trimeris. Evelo is developing oral biologic drugs that address the small intestinal axis, which plays a … Continue reading “Ex-Regeneron Exec Graham Named Evelo Bio Chief Development Officer”
Five Prime Therapeutics Taps Foundation Med’s Thomas Civik as New CEO
Thomas Civik has been appointed president and CEO of Five Prime Therapeutics (NASDAQ: [[ticker:FPRX]]). He comes to the South San Francisco biotech from Foundation Medicine, where he was chief commercial officer. Civik will also join Five Prime’s board of directors. William Ringo, interim CEO since last September, will step down from the C-suite and continue … Continue reading “Five Prime Therapeutics Taps Foundation Med’s Thomas Civik as New CEO”
With Harvard Tech and $5M, PIC Therapeutics Takes Aim at Cancer
Some of the targets in cancer research are visible and well known, but they’re hard to hit with new drugs all the same. PIC Therapeutics is developing medicines aiming for one particularly elusive group of proteins, and the startup’s early research has attracted financial support from some prominent names in the life sciences industry. PIC … Continue reading “With Harvard Tech and $5M, PIC Therapeutics Takes Aim at Cancer”
Cerevance Raises $45M to Advance Brain Disease Research & Development
Cerevance, a biotech focused on developing new treatments for brain diseases, has added $45 million to its coffers in a Series B financing round from investors including the venture capital arm of Google parent company Alphabet and billionaire philanthropist Bill Gates. On Tuesday the Boston-based company said the money would allow it to continue identifying … Continue reading “Cerevance Raises $45M to Advance Brain Disease Research & Development”
GSK and Sanofi Team Up on COVID-19 Vaccine, Aim for Clinic This Year
[Updated, 3:13 p.m. See below.] Pharmaceutical giants GlaxoSmithKline and Sanofi are teaming up on COVID-19 research, aiming to combine their respective technologies in a new vaccine that could start clinical trials in coming months. The full details of the agreement, which was announced Tuesday, are still being finalized. But the companies say the vaccine would … Continue reading “GSK and Sanofi Team Up on COVID-19 Vaccine, Aim for Clinic This Year”
Arcturus Poised to Move Liver Drug, COVID-19 Vaccine Into Clinic
Messenger RNA drug developer Arcturus Therapeutics is ready to kick off its first-ever human trials this year, beginning clinical evaluation of its lead drug candidate and testing a vaccine designed to target the novel coronavirus. The San Diego biotech on Monday announced it had received the FDA’s OK to enter into the clinic with ARCT-810, … Continue reading “Arcturus Poised to Move Liver Drug, COVID-19 Vaccine Into Clinic”
Japan’s Kyowa Kirin Pays MEI Pharma $100M in Blood Cancer Drug Pact
MEI Pharma is expanding a 2018 deal with Japanese biopharma Kyowa Kirin giving the company the development and commercialization rights to one of its investigational blood cancer drugs in that country. Kyowa has agreed to pay $100 million up front for rights to MEI-401 outside of the United States, and to jointly develop and—if approved—promote … Continue reading “Japan’s Kyowa Kirin Pays MEI Pharma $100M in Blood Cancer Drug Pact”
More Trust, Collaboration in Pharma Needed to Reap Benefits of Data Science
Limited data isn’t an issue when it comes to how to best use computational tools to better prevent disease and treat patients—but how to more efficiently analyze existing information is. Industry veterans with experience in life sciences and data science floated their ideas about how the pharmaceutical industry could better plug in to the “big … Continue reading “More Trust, Collaboration in Pharma Needed to Reap Benefits of Data Science”
Ex-Celgene Exec Brownstein Named Chief Medical Officer of Cellectis
Cellectis (NASDAQ: [[ticker:CLLS]]) has appointed Carrie Brownstein to serve as its chief medical officer. She worked most recently at Celgene as vice president of global clinical research and development and therapeutic area head for myeloid diseases. Celgene was acquired by Bristol Myers Squibb (NYSE: [[ticker:BMY]]) last year. Brownstein’s experience also includes positions at Regeneron Pharmaceuticals … Continue reading “Ex-Celgene Exec Brownstein Named Chief Medical Officer of Cellectis”
Blackstone Pays Alnylam $1B to Grab a Stake in RNAi Drug Inclisiran
Seven years ago Alnylam Pharmaceuticals sold rights to one of its preclinical drugs, gaining upfront cash and $180 million in potential milestone payments, plus royalties, for a therapy taking a novel approach to lowering cholesterol. On Monday, the company announced the sale of half of the royalties it’s owed to private equity firm Blackstone for … Continue reading “Blackstone Pays Alnylam $1B to Grab a Stake in RNAi Drug Inclisiran”
AstraZeneca Wins First FDA Drug Nod for NF1, a Rare Genetic Disorder
An AstraZeneca drug designed to block tumor growth is now approved as a treatment for neurofibromatosis type 1 (NF1), a rare inherited disorder that leads to tumors on nerves throughout the body. The FDA’s Friday decision for the drug, selumetinib (Koselugo), makes it the first approved treatment for NF1. It’s also the latest twist in … Continue reading “AstraZeneca Wins First FDA Drug Nod for NF1, a Rare Genetic Disorder”
Akero Heads to Top of Class in NASH; Genfit Says Pandemic Won’t Delay Data
Akero’s FGF21 analog yields 63 percent to 72 percent relative hepatic fat reduction in Phase 2a study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase 3 NASH readout. FGF21 analogs comprise one of the more crowded classes in nonalcoholic steatohepatitis (NASH) … Continue reading “Akero Heads to Top of Class in NASH; Genfit Says Pandemic Won’t Delay Data”
Adaptive Biotechnologies Names Mark Adams Chief Technical Officer
Adaptive Biotechnologies (NASDAQ: [[ticker:ADPT]]) has appointed Mark Adams to serve as its chief technical officer. He was most recently managing director of healthcare advanced analytics at SVB Leerink. Adams is succeeding Sean Nolan, who will remain at Seattle-based Adaptive, taking on a new role as distinguished engineer. Adaptive is developing therapies based on insight into … Continue reading “Adaptive Biotechnologies Names Mark Adams Chief Technical Officer”
Tango Therapeutics Appoints Beckman as Chief Financial Officer
Daniella Beckman is now the permanent chief financial officer of Tango Therapeutics after holding the role in an interim capacity. Her experience includes financial positions at Idenix Pharmaceuticals, Coley Pharmaceuticals, Biogen Idec, and PricewaterhouseCoopers. Cambridge, MA-based Tango recently raised $60 million in Series B financing to support continued development of cancer drugs based on a … Continue reading “Tango Therapeutics Appoints Beckman as Chief Financial Officer”
Biotech Roundup: GSK’s Ante, Shakeup at Sage, Telehealth’s Rise & More
The COVID-19 pandemic has stopped enrollment in many clinical trials and postponed the start of others but there is still life in the life sciences sector. The coronavirus research is expected. It’s the other activity that might come as a surprise. Two biotech companies have gone public in the past week; each upsized its offering and … Continue reading “Biotech Roundup: GSK’s Ante, Shakeup at Sage, Telehealth’s Rise & More”
Aravive Promotes Chief Scientific Officer Gail McIntyre to CEO
Aravive (NASDAQ: ARAV) on Thursday said Gail McIntyre, the company’s chief scientific officer, has been promoted to CEO. McIntyre, who joined the company since 2016, succeeds Rekha Hemrajani, who has resigned, along with three board directors. The company called the leadership transition a “natural evolution” following its company’s reverse merger in June 2018 with Versartis, … Continue reading “Aravive Promotes Chief Scientific Officer Gail McIntyre to CEO”
Bolt Bio Adds Mayo Clinic’s Edith Perez as Chief Medical Officer
Bolt Biotherapeutics has added longtime Mayo Clinic professor Edith Perez to its C-suite as chief medical officer. Perez, who has taught at Mayo for two decades and heads its Breast Cancer Translational Genomics program, will maintain a clinical affiliation. She previously served another stint in industry, spending three years as head of US medical affairs for Genentech’s … Continue reading “Bolt Bio Adds Mayo Clinic’s Edith Perez as Chief Medical Officer”
Pfizer, BioNTech Say mRNA COVID-19 Vaccine Trials May Start This Month
Multiple COVID-19 vaccine candidates that use a new technology called messenger RNA are now being readied for clinical trials that Pfizer and BioNTech plan to start in coming weeks. The partnership pairs the mRNA vaccine technology of BioNTech (NASDAQ: [[ticker:BNTX]]) with the vaccine and clinical trial experience of Pfizer (NYSE: [[ticker:PFE]]). The companies said Thursday … Continue reading “Pfizer, BioNTech Say mRNA COVID-19 Vaccine Trials May Start This Month”
Tango Adds $60M in CRISPR Hunt for Synthetically Lethal Cancer Drugs
CRISPR is key to the cancer drugs that Tango Therapeutics is developing, but the startup isn’t out to edit disease-causing genes. Tango uses the technology as a tool for finding drug targets, in research that has yielded a pipeline of compounds. Now it has $60 million to continue that work. The Series B round of … Continue reading “Tango Adds $60M in CRISPR Hunt for Synthetically Lethal Cancer Drugs”
Investors Bet on Next-Gen Telehealth as COVID-19 Fuels Adoption
Talking to a healthcare provider from the safety of one’s own home make more sense than ever today. Tyto Care offers a way to do so, plus a device that allows consumers to perform exams and transmit video, images, and sounds to their provider. This week the telehealth company doubled its outside investment to fuel … Continue reading “Investors Bet on Next-Gen Telehealth as COVID-19 Fuels Adoption”
Gilead Heightens Inflammatory Disease Focus With Second Genome Microbiome Deal
Gilead Sciences has signed an agreement with South San Francisco biotech Second Genome to use its microbiome drug development expertise to advance the compounds it is evaluating in inflammatory disease and to identify new ones. “There is a growing body of evidence that the microbiome plays an important role in disease progression and treatment response … Continue reading “Gilead Heightens Inflammatory Disease Focus With Second Genome Microbiome Deal”
Organovo Future Unclear After Shareholders Reject Tarveda Merger
A planned merger between struggling 3-D “bioprinter” Organovo and Tarveda Therapeutics, a privately held cancer drug developer looking to join the public markets through a reverse merger, has fallen through. Organovo (NASDAQ: [[ticker:ONVO]]) management announced in mid-December that its board of directors and Tarveda’s had approved the companies’ combination. But Organovo shareholders, who under the … Continue reading “Organovo Future Unclear After Shareholders Reject Tarveda Merger”
Roche Pays $190M to Start RNA Drug Alliance With Arrakis Therapeutics
Some diseases have proven difficult to address using conventional tools of drug discovery that target disease-causing proteins. Roche is placing a $190 million bet on Arrakis Therapeutics, a startup whose technology aims for RNA—carriers of the genetic instructions that make these proteins in the first place. The cash, an upfront payment to Waltham, MA-based Arrakis, … Continue reading “Roche Pays $190M to Start RNA Drug Alliance With Arrakis Therapeutics”
Keros Therapeutics Raises $96M in Upsized IPO to Fuel Clinical Tests
The financial markets may remain volatile but Keros Therapeutics (NASDAQ: [[ticker:KROS]]) managed to raise more money in its public market debut than it had initially planned. Late Tuesday, the Lexington, MA-based company offered 6 million shares for $16 apiece, the high end of its projected price range. Keros had previously planned to offer 5 million … Continue reading “Keros Therapeutics Raises $96M in Upsized IPO to Fuel Clinical Tests”
Inovio Begins Experimental COVID-19 Vaccine Tests in Healthy Volunteers
Inovio Pharmaceuticals, one of the biotechs developing a vaccine to prevent COVID-19, has received the FDA’s OK to start testing its candidate in healthy volunteers. The Plymouth Meeting, PA-based company, which also conducts research in San Diego, plans to enroll as many as 40 adults across two trial locations. Inovio (NASDAQ: [[ticker:INO]]) said Monday it … Continue reading “Inovio Begins Experimental COVID-19 Vaccine Tests in Healthy Volunteers”
Sage Restructuring Halves Staff, Turns Focus to Failed Depression Drug
Sage Therapeutics is cutting workers who sell its only commercialized drug in a corporate reorganization that it says allows it to focus on clinical-stage compounds, including a depression treatment that failed a pivotal test late last year. The corporate shakeup will eliminate the jobs of 340 employees, or about 53 percent of its staff, Sage … Continue reading “Sage Restructuring Halves Staff, Turns Focus to Failed Depression Drug”
Creating Consistent Value in Biotech Without Diluting Stakeholders
One of the greatest challenges for pre-commercial biotech companies is consistently generating capital necessary for operating costs and for R&D of new products that provide value to stakeholders, both for investors and patients. At OSE Immunotherapeutics we implemented a business model that allows us to be one of the rare French biotech companies without commercial … Continue reading “Creating Consistent Value in Biotech Without Diluting Stakeholders”
Polyneuron Adds Polyphor’s Debra Barker as Chief Medical Officer
Polyneuron Pharmaceuticals, a Swiss biotech that is developing a new class of biodegradable glycopolymers for the treatment of autoimmune diseases, has appointed Debra Barker as its chief medical officer. Most recently Barker was chief medical and development officer at Polyphor, which she left for personal reasons at the end of 2018. Her previous experience includes … Continue reading “Polyneuron Adds Polyphor’s Debra Barker as Chief Medical Officer”
Morphic Appoints ArQule’s Schegerin Chief Financial, Operating Officer
Morphic Therapeutic (NASDAQ: [[ticker:MORF]]) has named Marc Schegerin as its chief financial officer and chief operating officer. Schegerin was most recently CFO at cancer drug developer ArQule, which Merck (NYSE: [[ticker:MRK]]) agreed to acquire in December for $2.7 billion. Schegerin joins another recent addition to Morphic’s C suite, Peter Linde, who joined the company in … Continue reading “Morphic Appoints ArQule’s Schegerin Chief Financial, Operating Officer”